This document discusses the maturity and adoption of Manufacturing Execution Systems (MES) in the pharmaceutical industry. It finds that MES has matured positively over the past 16+ years and is becoming a recognized best practice. A survey found that 47% of respondents had deployed electronic MES in manufacturing facilities, though only 31% had fully paperless solutions. The primary drivers for MES adoption were improving quality (39%) and production (41%), which together accounted for almost 80% of reasons. MES provides benefits like reduced costs, improved production capacity, and better financial costing. Regulatory agencies also view MES positively as helping ensure quality and risk mitigation.
Global CyberSoft is an IT services company that provides factory automation, ERP business solutions, testing services, and business process outsourcing. The document discusses how Global CyberSoft offers integrated ERP and MES solutions to enable effective manufacturing by integrating enterprise and control systems. It provides an overview of ERP and MES systems and how fully integrating the two can improve adoption and performance for manufacturing industries.
The document provides an introduction to Manufacturing Execution Systems (MES) by Michael McClellan, the president of MES Solutions Incorporated. It describes that MES bridges the gap between planning systems like ERP and control systems on the plant floor by collecting online information to manage resources. MES provides benefits like reduced cycle times, inventory, and lead times as well as improved quality and customer service by empowering plant operations with real-time data. The core functions of MES include interfacing with planning systems, managing work orders, tracking inventory and labor, and collecting production data to optimize manufacturing execution.
This document describes Siemens' Manufacturing Execution System (MES) solution called SIMATIC IT. Some key points:
- SIMATIC IT establishes transparency in manufacturing plants and fully integrates information flow.
- It offers a range of components to optimize planning, execution, documentation and processes, enabling seamless integration.
- Using SIMATIC IT can help companies achieve greater efficiency, quality, delivery reliability, shorter cycle times and full traceability.
Axcend is an IT consulting firm that provides ERP and OEE solutions to manufacturing clients. It partners with QAD to implement their ERP software, and also offers an OEE solution to measure production efficiency. The OEE solution calculates key metrics like availability, performance, and quality using real-time equipment data. Implementing an OEE system involves assessing a client's operations, developing an automatic data collection system, calculating ROI, and integrating the system with other business applications. OEE reports and dashboards provide visibility into downtime causes and help manufacturers reduce costs and improve productivity.
MES - Manufacturing Execution System ExplainedMRPeasy
Manufacturing Execution System - what is it and what it is not - too many manufacturers get it wrong. Find out more information at http://www.mrpeasy.com
Manufacturing Execution System for Industry-I am pleased to share details about our successfully working model, as how we can provide you with innovative & industry proven Plant Intelligence Solutions for Automotive Manufacturing Plant like yours to give you following benefits in Real Time Environment:
• Informed decisions based on Data Analytics
• Streamlined and Optimized Operations
• Improved Productivity
• Reduce Total Defects
• Reduced Inventory
• Lean, “Smart” MES approach and application coverage for low TCO
• Improved return on assets and investments (ROA/ ROI)
• Improved Equipment Up-Time
• Improved responsiveness, improved plant throughput time
• Enhanced Real Time visibility into production data
We have successfully served as per expectations of many End-Users in Manufacturing, Food & Beverage, Pharma, Oil & Gas, Petrochemical , Cement, Power, & metals Industry. We have more than 5000+ software installations throughout India with proven track record in almost every industry vertical and have delivered projects to 40+ countries in every continent including Americas, Europe, Asia, Africa, and Australia.
Optiflow-Le Manufacturing Execution System is a suite of scalable integrated tools, that synchronize your plant-floor operations with supply chain, materials, inventory & business processes, resulting in greater overall performance.
Includes Factory Intelligence, PDM / PLM, Detailed scheduling & Sequencing, BPM Modeler, Capacity Management, Workforce Management, Integration & Collaboration, Data Acquisition and advanced measurement tools such as OEE & OLE.
Global CyberSoft is an IT services company that provides factory automation, ERP business solutions, testing services, and business process outsourcing. The document discusses how Global CyberSoft offers integrated ERP and MES solutions to enable effective manufacturing by integrating enterprise and control systems. It provides an overview of ERP and MES systems and how fully integrating the two can improve adoption and performance for manufacturing industries.
The document provides an introduction to Manufacturing Execution Systems (MES) by Michael McClellan, the president of MES Solutions Incorporated. It describes that MES bridges the gap between planning systems like ERP and control systems on the plant floor by collecting online information to manage resources. MES provides benefits like reduced cycle times, inventory, and lead times as well as improved quality and customer service by empowering plant operations with real-time data. The core functions of MES include interfacing with planning systems, managing work orders, tracking inventory and labor, and collecting production data to optimize manufacturing execution.
This document describes Siemens' Manufacturing Execution System (MES) solution called SIMATIC IT. Some key points:
- SIMATIC IT establishes transparency in manufacturing plants and fully integrates information flow.
- It offers a range of components to optimize planning, execution, documentation and processes, enabling seamless integration.
- Using SIMATIC IT can help companies achieve greater efficiency, quality, delivery reliability, shorter cycle times and full traceability.
Axcend is an IT consulting firm that provides ERP and OEE solutions to manufacturing clients. It partners with QAD to implement their ERP software, and also offers an OEE solution to measure production efficiency. The OEE solution calculates key metrics like availability, performance, and quality using real-time equipment data. Implementing an OEE system involves assessing a client's operations, developing an automatic data collection system, calculating ROI, and integrating the system with other business applications. OEE reports and dashboards provide visibility into downtime causes and help manufacturers reduce costs and improve productivity.
MES - Manufacturing Execution System ExplainedMRPeasy
Manufacturing Execution System - what is it and what it is not - too many manufacturers get it wrong. Find out more information at http://www.mrpeasy.com
Manufacturing Execution System for Industry-I am pleased to share details about our successfully working model, as how we can provide you with innovative & industry proven Plant Intelligence Solutions for Automotive Manufacturing Plant like yours to give you following benefits in Real Time Environment:
• Informed decisions based on Data Analytics
• Streamlined and Optimized Operations
• Improved Productivity
• Reduce Total Defects
• Reduced Inventory
• Lean, “Smart” MES approach and application coverage for low TCO
• Improved return on assets and investments (ROA/ ROI)
• Improved Equipment Up-Time
• Improved responsiveness, improved plant throughput time
• Enhanced Real Time visibility into production data
We have successfully served as per expectations of many End-Users in Manufacturing, Food & Beverage, Pharma, Oil & Gas, Petrochemical , Cement, Power, & metals Industry. We have more than 5000+ software installations throughout India with proven track record in almost every industry vertical and have delivered projects to 40+ countries in every continent including Americas, Europe, Asia, Africa, and Australia.
Optiflow-Le Manufacturing Execution System is a suite of scalable integrated tools, that synchronize your plant-floor operations with supply chain, materials, inventory & business processes, resulting in greater overall performance.
Includes Factory Intelligence, PDM / PLM, Detailed scheduling & Sequencing, BPM Modeler, Capacity Management, Workforce Management, Integration & Collaboration, Data Acquisition and advanced measurement tools such as OEE & OLE.
Manufacturing Execution Systems (MES) fill the gap between plant control systems (PCS) on the factory floor and corporate ERP systems. MES connect disparate factory systems, ensure compliance, and provide critical manufacturing data and alerts. They are implemented by specialized MES vendors who understand production needs better than traditional ERP vendors. Camstar's InSite is an MES that provides enterprise integration, business intelligence, and production execution across multiple plants through solutions like LiveConnect, LiveView, and LiveRelay. InSite supports multi-site manufacturing processes through information sharing and unit transfers between specialized or general plants and subcontractors. While still a developing market, MES are poised to transform manufacturing IT systems.
PharmaSuite manufacturing execution system (MES) software, the new EBR solutionXavier Solà
The document discusses the benefits of implementing an advanced electronic batch recording (EBR) system integrated with a manufacturing execution system (MES) for pharmaceutical manufacturers. It summarizes that such a system can help optimize production processes, speed up time-to-market, reduce costs through greater efficiencies and reduced waste and errors, ease regulatory compliance demands, and enable serialization capabilities to combat counterfeiting as required by emerging regulations. Implementing an EBR/MES system provides opportunities to cut batch review times, lower operating costs, improve inventory management, and support global compliance requirements in a cost-effective manner.
Manufacturing Execution Systems (MES) coordinate activities on the shop floor to optimize plant operations. MES provide visibility and control of production processes by collecting real-time data from equipment and integrating it with ERP systems. Key functions of MES include production tracking, quality management, resource allocation, and maintenance management to improve operational efficiency.
Industry 4.0 Aligned Manufacturing MES SoftwareCantier Systems
The document discusses Industry 4.0 and how it enables smart manufacturing through technologies like cyber-physical systems, the Internet of Things, cloud computing, and big data. It states that manufacturing execution systems (MES) play a fundamental role as the base for smart production solutions by providing real-time operational data and enabling timely decision-making. The document promotes Cantier MES software as a configurable and scalable platform that can serve as a gateway to achieving smart manufacturing goals.
1) Siemens provides manufacturing execution system (MES) software called SIMATIC IT that integrates across various parts of the manufacturing process from engineering to production.
2) SIMATIC IT uses the ISA-95 standard to promote interoperability between MES, ERP, and other systems.
3) The document describes how SIMATIC IT helps manufacturers optimize costs, quality, and production flexibility through integration and visibility across global operations.
Honeywell User's Group Almirall's MES case studyDavid Badia
The document discusses the implementation of a POMS MES system at Almirall, a pharmaceutical company. It describes how the MES system improved quality and production operations through integrated management of processes like purchasing, manufacturing, quality control and logistics. Key benefits included improved traceability, compliance and flexibility to remain competitive through continuous optimization of manufacturing execution.
This document discusses approaches to implementing Manufacturing Execution Systems (MES). It begins by defining MES and describing the ISA-95 manufacturing operations model. It then contrasts two approaches: the "big bang" implementation of all MES functionality at once versus incremental implementation by selecting individual capabilities. The document advocates for the incremental approach, arguing it has advantages in terms of cost, change management, implementation complexity and return on investment analysis. It provides guidance on developing a long-term roadmap for MES implementation, including establishing goals, identifying opportunities and building implementation plans in a collaborative manner.
FDA Data Integrity Issues - DMS hot fixesVidyasagar P
The document discusses data integrity, including popular causes of integrity issues, consequences, and fixes related to document management systems. It provides definitions of data integrity and discusses regulatory requirements around integrity from agencies like the FDA. Specifically, it summarizes the FDA's 21 CFR Part 11 regulation, which considers electronic records equivalent to paper if certain controls are in place. It also discusses application integrity policies and concludes that ensuring data integrity is important to rebuild regulatory trust if issues are found.
Document management system for Pharmaceuticalbaseinfo
The document discusses a document management system for pharmaceutical companies built on the Alfresco platform. It notes that pharmaceutical companies operate in a highly regulated environment and need effective document management. The system allows companies to automate business processes, provide a knowledge base to users, and integrate with quality management, manufacturing, and other electronic document systems used in the manufacturing process. It provides features like digital signatures, audit trails, document version control, and mobile access to help companies comply with regulations.
The document discusses enterprise resource planning (ERP) systems and their key components and benefits. It provides an overview of common ERP modules like finance, manufacturing, sales and distribution. It also summarizes several major ERP vendors like SAP, Oracle, PeopleSoft and describes some of their flagship ERP products.
This document provides an overview of GAMP (Good Automated Manufacturing Practice) guidelines for validation of computer systems used in regulated industries. It discusses the history of GAMP, key terms and concepts in validation like validation life cycle, risk management, categories of software. It also summarizes the validation requirements for different categories of software and records as per GAMP-4 guidelines. The document emphasizes that validation is important to ensure computer systems consistently produce intended results and meet safety standards.
MES systems fill the communication gap between manufacturing planning systems like ERP and the control systems that run production equipment. MES provides overall control and management of the factory floor, coordinates functions to optimize plant activities, and provides visibility into operations. Key benefits include increased operational excellence, improved asset utilization, reduced costs from shorter lead times and less waste, and better product quality. MES components coordinate dispatching and tracking of production, quality management, and resource allocation.
Electronic Batch Manufacturing records and MES in PharmaceuticalNilay Sharma
The document discusses the adoption of electronic batch manufacturing records (eBMR) and manufacturing execution systems (MES) in the pharmaceutical industry. It notes that pharmaceutical companies are under pressure to minimize human errors and ensure regulatory compliance, driving adoption of technology solutions. While ERP systems tracked workflows and materials, they lacked control over manufacturing processes. eBMR and MES help address this by enabling equipment to communicate process parameters and measurements digitally in real-time rather than relying on manual recording. This increases accuracy, productivity and ensures compliance. The document provides an overview of Base E12 MES and eBMR software.
Electronic batch record management in pharmaceutical industrysadhish jain
The document discusses electronic batch record (EBR) systems in the pharmaceutical industry. It begins by explaining that pharmaceutical companies have traditionally used paper-based batch records but are now shifting to EBR systems to reduce paperwork. It then covers the benefits of EBR systems, such as improved accuracy, reduced costs and cycle times. The document also outlines four types of EBR systems - paper, document management, data collection and manufacturing execution - and discusses challenges in implementing EBR systems. It concludes that EBR systems can significantly reduce the burden of paperwork in pharmaceutical manufacturing.
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
- The document discusses data integrity, which refers to maintaining accurate and consistent data over its entire lifecycle. This is important for the regulated healthcare industry as quality decisions are based on data.
- The FDA uses the ALCOA criteria (Attributable, Legible, Contemporaneous, Original, Accurate) to define expectations for electronic data. Regulatory agencies now focus heavily on data integrity due to instances of fabricated documents and errors.
- Common data integrity issues found by agencies include non-contemporaneous recording, backdating records, re-running samples until desired results are obtained, and data fabrication. Ensuring data integrity helps prevent regulatory actions like warning letters or import bans against companies.
The document outlines the project preparation and planning process for implementing new CRM and ERP systems, including forming project teams, drafting plans and documentation, procuring vendors, and designing "as-is" and "to-be" business processes for finance, supply chain management, and HR modules. It also describes subsequent phases for system design, testing, data migration, user acceptance testing, and project go-live. A sample risk register is included to manage potential risks to the project.
This document discusses the importance of quality management systems for clinical laboratories. It notes that laboratories conduct highly complex, regulated operations and must meet stringent requirements to ensure accuracy, safety, and customer satisfaction. The document outlines some of the errors that can occur in laboratories and their consequences. It argues that a quality management system is necessary to minimize errors, improve processes, and ensure compliance. The document acknowledges there is an initial cost to implementing a quality system but notes that the cost is outweighed by reductions in errors, increased efficiency and customer satisfaction.
Companies’ perception toward manufacturing execution systems IJECEIAES
The use of information systems in manufacturing sector is very crucial to reach a high level of operational excellence and improve companies’ competitiveness. The use of such systems will definitely increase in the upcoming years, considering the digitalization strategies. Manufacturing execution systems gained a lot of attention in recent years due to showcased benefits in production management operations. Companies that adopted such systems witnessed an increase in process efficiency and enhancements with regards to cost savings and products quality. This paper seeks to analyze what makes the usage of manufacturing execution systems successful among manufacturing companies. We analyzed how the integration capabilities of such systems with other business applications and the company profile impact their usage and consequently the perceived benefits. A case study was conducted with 51 manufacturing companies and data were analyzed using partial least square structural equation modeling technique. The results confirmed the positive and significant impact of the company profile and solution integration capabilities on system usage. In addition, a ranking of solution modules importance for companies was also provided.
Electronic batch record management in pharmaceutical industryVikrant Kalal
The document discusses electronic batch record (EBR) systems in the pharmaceutical industry. It begins by explaining that pharmaceutical companies have traditionally used paper-based batch records but are now shifting to EBR systems to reduce paperwork. It then covers the benefits of EBR systems, such as improved accuracy, reduced costs and cycle times. The document also outlines four types of EBR systems - paper, document management, data collection and manufacturing execution - and discusses challenges in implementing EBR systems. It concludes that EBR systems can significantly reduce the burden of paperwork in pharmaceutical manufacturing.
Manufacturing Execution Systems (MES) fill the gap between plant control systems (PCS) on the factory floor and corporate ERP systems. MES connect disparate factory systems, ensure compliance, and provide critical manufacturing data and alerts. They are implemented by specialized MES vendors who understand production needs better than traditional ERP vendors. Camstar's InSite is an MES that provides enterprise integration, business intelligence, and production execution across multiple plants through solutions like LiveConnect, LiveView, and LiveRelay. InSite supports multi-site manufacturing processes through information sharing and unit transfers between specialized or general plants and subcontractors. While still a developing market, MES are poised to transform manufacturing IT systems.
PharmaSuite manufacturing execution system (MES) software, the new EBR solutionXavier Solà
The document discusses the benefits of implementing an advanced electronic batch recording (EBR) system integrated with a manufacturing execution system (MES) for pharmaceutical manufacturers. It summarizes that such a system can help optimize production processes, speed up time-to-market, reduce costs through greater efficiencies and reduced waste and errors, ease regulatory compliance demands, and enable serialization capabilities to combat counterfeiting as required by emerging regulations. Implementing an EBR/MES system provides opportunities to cut batch review times, lower operating costs, improve inventory management, and support global compliance requirements in a cost-effective manner.
Manufacturing Execution Systems (MES) coordinate activities on the shop floor to optimize plant operations. MES provide visibility and control of production processes by collecting real-time data from equipment and integrating it with ERP systems. Key functions of MES include production tracking, quality management, resource allocation, and maintenance management to improve operational efficiency.
Industry 4.0 Aligned Manufacturing MES SoftwareCantier Systems
The document discusses Industry 4.0 and how it enables smart manufacturing through technologies like cyber-physical systems, the Internet of Things, cloud computing, and big data. It states that manufacturing execution systems (MES) play a fundamental role as the base for smart production solutions by providing real-time operational data and enabling timely decision-making. The document promotes Cantier MES software as a configurable and scalable platform that can serve as a gateway to achieving smart manufacturing goals.
1) Siemens provides manufacturing execution system (MES) software called SIMATIC IT that integrates across various parts of the manufacturing process from engineering to production.
2) SIMATIC IT uses the ISA-95 standard to promote interoperability between MES, ERP, and other systems.
3) The document describes how SIMATIC IT helps manufacturers optimize costs, quality, and production flexibility through integration and visibility across global operations.
Honeywell User's Group Almirall's MES case studyDavid Badia
The document discusses the implementation of a POMS MES system at Almirall, a pharmaceutical company. It describes how the MES system improved quality and production operations through integrated management of processes like purchasing, manufacturing, quality control and logistics. Key benefits included improved traceability, compliance and flexibility to remain competitive through continuous optimization of manufacturing execution.
This document discusses approaches to implementing Manufacturing Execution Systems (MES). It begins by defining MES and describing the ISA-95 manufacturing operations model. It then contrasts two approaches: the "big bang" implementation of all MES functionality at once versus incremental implementation by selecting individual capabilities. The document advocates for the incremental approach, arguing it has advantages in terms of cost, change management, implementation complexity and return on investment analysis. It provides guidance on developing a long-term roadmap for MES implementation, including establishing goals, identifying opportunities and building implementation plans in a collaborative manner.
FDA Data Integrity Issues - DMS hot fixesVidyasagar P
The document discusses data integrity, including popular causes of integrity issues, consequences, and fixes related to document management systems. It provides definitions of data integrity and discusses regulatory requirements around integrity from agencies like the FDA. Specifically, it summarizes the FDA's 21 CFR Part 11 regulation, which considers electronic records equivalent to paper if certain controls are in place. It also discusses application integrity policies and concludes that ensuring data integrity is important to rebuild regulatory trust if issues are found.
Document management system for Pharmaceuticalbaseinfo
The document discusses a document management system for pharmaceutical companies built on the Alfresco platform. It notes that pharmaceutical companies operate in a highly regulated environment and need effective document management. The system allows companies to automate business processes, provide a knowledge base to users, and integrate with quality management, manufacturing, and other electronic document systems used in the manufacturing process. It provides features like digital signatures, audit trails, document version control, and mobile access to help companies comply with regulations.
The document discusses enterprise resource planning (ERP) systems and their key components and benefits. It provides an overview of common ERP modules like finance, manufacturing, sales and distribution. It also summarizes several major ERP vendors like SAP, Oracle, PeopleSoft and describes some of their flagship ERP products.
This document provides an overview of GAMP (Good Automated Manufacturing Practice) guidelines for validation of computer systems used in regulated industries. It discusses the history of GAMP, key terms and concepts in validation like validation life cycle, risk management, categories of software. It also summarizes the validation requirements for different categories of software and records as per GAMP-4 guidelines. The document emphasizes that validation is important to ensure computer systems consistently produce intended results and meet safety standards.
MES systems fill the communication gap between manufacturing planning systems like ERP and the control systems that run production equipment. MES provides overall control and management of the factory floor, coordinates functions to optimize plant activities, and provides visibility into operations. Key benefits include increased operational excellence, improved asset utilization, reduced costs from shorter lead times and less waste, and better product quality. MES components coordinate dispatching and tracking of production, quality management, and resource allocation.
Electronic Batch Manufacturing records and MES in PharmaceuticalNilay Sharma
The document discusses the adoption of electronic batch manufacturing records (eBMR) and manufacturing execution systems (MES) in the pharmaceutical industry. It notes that pharmaceutical companies are under pressure to minimize human errors and ensure regulatory compliance, driving adoption of technology solutions. While ERP systems tracked workflows and materials, they lacked control over manufacturing processes. eBMR and MES help address this by enabling equipment to communicate process parameters and measurements digitally in real-time rather than relying on manual recording. This increases accuracy, productivity and ensures compliance. The document provides an overview of Base E12 MES and eBMR software.
Electronic batch record management in pharmaceutical industrysadhish jain
The document discusses electronic batch record (EBR) systems in the pharmaceutical industry. It begins by explaining that pharmaceutical companies have traditionally used paper-based batch records but are now shifting to EBR systems to reduce paperwork. It then covers the benefits of EBR systems, such as improved accuracy, reduced costs and cycle times. The document also outlines four types of EBR systems - paper, document management, data collection and manufacturing execution - and discusses challenges in implementing EBR systems. It concludes that EBR systems can significantly reduce the burden of paperwork in pharmaceutical manufacturing.
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
- The document discusses data integrity, which refers to maintaining accurate and consistent data over its entire lifecycle. This is important for the regulated healthcare industry as quality decisions are based on data.
- The FDA uses the ALCOA criteria (Attributable, Legible, Contemporaneous, Original, Accurate) to define expectations for electronic data. Regulatory agencies now focus heavily on data integrity due to instances of fabricated documents and errors.
- Common data integrity issues found by agencies include non-contemporaneous recording, backdating records, re-running samples until desired results are obtained, and data fabrication. Ensuring data integrity helps prevent regulatory actions like warning letters or import bans against companies.
The document outlines the project preparation and planning process for implementing new CRM and ERP systems, including forming project teams, drafting plans and documentation, procuring vendors, and designing "as-is" and "to-be" business processes for finance, supply chain management, and HR modules. It also describes subsequent phases for system design, testing, data migration, user acceptance testing, and project go-live. A sample risk register is included to manage potential risks to the project.
This document discusses the importance of quality management systems for clinical laboratories. It notes that laboratories conduct highly complex, regulated operations and must meet stringent requirements to ensure accuracy, safety, and customer satisfaction. The document outlines some of the errors that can occur in laboratories and their consequences. It argues that a quality management system is necessary to minimize errors, improve processes, and ensure compliance. The document acknowledges there is an initial cost to implementing a quality system but notes that the cost is outweighed by reductions in errors, increased efficiency and customer satisfaction.
Companies’ perception toward manufacturing execution systems IJECEIAES
The use of information systems in manufacturing sector is very crucial to reach a high level of operational excellence and improve companies’ competitiveness. The use of such systems will definitely increase in the upcoming years, considering the digitalization strategies. Manufacturing execution systems gained a lot of attention in recent years due to showcased benefits in production management operations. Companies that adopted such systems witnessed an increase in process efficiency and enhancements with regards to cost savings and products quality. This paper seeks to analyze what makes the usage of manufacturing execution systems successful among manufacturing companies. We analyzed how the integration capabilities of such systems with other business applications and the company profile impact their usage and consequently the perceived benefits. A case study was conducted with 51 manufacturing companies and data were analyzed using partial least square structural equation modeling technique. The results confirmed the positive and significant impact of the company profile and solution integration capabilities on system usage. In addition, a ranking of solution modules importance for companies was also provided.
Electronic batch record management in pharmaceutical industryVikrant Kalal
The document discusses electronic batch record (EBR) systems in the pharmaceutical industry. It begins by explaining that pharmaceutical companies have traditionally used paper-based batch records but are now shifting to EBR systems to reduce paperwork. It then covers the benefits of EBR systems, such as improved accuracy, reduced costs and cycle times. The document also outlines four types of EBR systems - paper, document management, data collection and manufacturing execution - and discusses challenges in implementing EBR systems. It concludes that EBR systems can significantly reduce the burden of paperwork in pharmaceutical manufacturing.
Moving From Paper-Based Systems to Electronic Batch Records - InstantGMP™InstantGMP™
Technology is constantly evolving around us, and yet many manufacturers continue using paper-based systems to manage and record their activities while manufacturing. In recent times, many of these manufacturers, especially in pharmaceuticals and biotech, are making the move to a Manufacturing Execution System (MES) and Electronic Batch Records (EBR).
EBR management in the pharmaceutical industryPritam singh
This document discusses electronic batch record management systems in the pharmaceutical industry. It explains that electronic batch record (EBR) systems allow pharmaceutical companies to digitize their production batch records for increased efficiency compared to traditional paper-based systems. The document outlines the benefits of EBR systems, such as reduced cycle times and improved accuracy, but also notes challenges in selecting and implementing a suitable EBR software solution.
Pharmaceutical manufacturing software is a powerful tool that streamlines the pharmaceutical manufacturing process by automating key workflows and improving operational efficiency. Our software provides end-to-end visibility into the manufacturing process, enabling pharmaceutical companies to track and manage production in real-time. It also automates quality control processes, such as testing and compliance, to ensure that products meet regulatory standards. Our pharmaceutical manufacturing software is user-friendly and customizable, designed to meet the unique needs of pharmaceutical manufacturers. Contact us today to learn more about our pharmaceutical manufacturing software and take your manufacturing operations to the next level.
Good practice standardizes parameters and metrics across the entire operation to enable meaningful manufacturing decision support and continuous improvement. Frequently manufacturing and business parameters are combined into Key Performance Indicators (KPI) to simplify monitoring more complex functions. One commonly deployed KPI is Overall Equipment Effectiveness (OEE) which combines measures of availability, throughput and quality.
There exists tremendous value potential for companies coupling OEE with SPC, and making it part of manufacturing-decision support. It sets the company on the path to state-of-the-art manufacturing process management by enabling them to:
Apply SPC to automated OEE solutions – looking at single values of a KPI adds little to one’s process management capability, but using control charts and process capability analysis will enable developing world-class manufacturing;
Rapidly determine where improvement opportunities exist;
Focus on information, not data – data is the raw material; information provides the decision support that will improve performance levels.
Batch Manufacturers Require More Robust, Dock-to-Dock Control SystemsARC Advisory Group
Aware of the many choices in products and services, the consumer is conscious
of product price to value and demanding increased product quality,
safety, variety, and convenience. Most industries with batch manufacturing
processes are consolidating, requiring fewer plants to produce an
increased variety of products.
To survive, businesses that employ batch control processes must maximize
return on their assets while satisfying constantly changing consumer demands.
New government regulations continue to increase business costs.
Business and manufacturing process automation and integration have become
critical to business success.
While the functionality and standardization of commercial
off-the-shelf batch control systems has
increased dramatically in the last few years, they still
lack functionality needed to meet current and future
business requirements in the fine chemical, pharmaceutical,
food, and beverage industries. Standards
have been rapidly evolving and suppliers continue to
increase functionality needed to meet user business
requirements. Manufacturers in these industries can now develop an
automation strategy to meet current and future business needs using standard
products based on standards and not limited by technology.
The biopharmaceutical industries has more and more used computers to support and accelrate producing of their
products. Computer systems also are accustomed support routine offer of high quality products to boost production
process performance, scale back production prices, and improve product quality. it's vital that these systems square
measure suitable purpose from a business and restrictive perspective. Regulatory authorities treat a lack of regulatory
computer system compliance as a serious GxP deviation. The objective of regulated computer systems includes systems
used to manage data or support descion making subject to review by regulated authorities whether they are being
submitted because its impact on quality or on business. Investments in computer systems supporting the quality controls
to ensure that the process is followed correctly, reducing human error and the need to conduct manual checks,
Standardization of practices to build consistent ways of working, Speed-up of process cycle times by reducing wait times
and by improved scheduling...etc.Computer systems shouldn't be enforced only for restrictive compliance; operational
advantages must always be exploredas well. “U.S. Code of Federal Regulation 21 CFR Part 600, 606, and 610” and “EU
Directive 2003/94/EEC” are the prominent regulations reqested CSV, while “Volume 4 Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use - Annex 11: Computerised Systems” considered the main guidlines for
CSV in biopharmaceutical industries in European Union. This paper aims to provide simplifed guidance on the basic
requireents for computer system validation (CSV) based on the latest regulatory developments and industry trends. In
conclusion, CSV has the great impact on the processes improvement. Also the critical parameters of computer systems
validation for biopharmaceutical indsutries are highlighted.
#AHMED_HASHAM
https://medwinpublishers.com/OAJPR/computerized-systems-validation-csv-in-biopharmaceutical-industries.pdf
ERP Process industry sector such as Pharmaceutical, Chemical, Fertilizers, Pesticides and others are faced with new challenges and opportunities as they strive to keep pace with the rapid changes taking place worldwide in the Information Technology field.
This document is intended to serve as a guide for
professionals in the High Volume Manufacturing Industries who want to understand what Overall Equipment Effectiveness (OEE) can deliver for their business.
This document discusses the application of information technology (IT) systems in the pharmaceutical industry, called pharmacy informatics. It describes several key automated IT systems used in the industry, including computerized physician order entry (CPOE) systems, enterprise resource planning (ERP) systems, laboratory information management systems (LIMS), sales force automation (SFA), electronic batch records (EBR), and others. These systems help streamline workflows, improve efficiency and decision making, reduce errors, and ensure compliance with regulations. The increased use of automation and IT solutions has been important for the pharmaceutical industry given factors like high competition, less time to market drugs, and a highly regulated environment.
The future of medical device mfg executive briefPatti Stoll
The document discusses challenges facing the medical device manufacturing industry and how next-generation ERP systems can help address them. It notes that the aging Baby Boomer population will increase demand for medical devices but that cost containment measures pose challenges. It advocates that ERP systems can help manufacturers meet this rising demand while controlling costs through improved agility, collaboration, and ability to adapt to changing needs. Specifically, it recommends the Infor Industrial Manufacturing for Medical Devices solution to help streamline operations from production to service to compliance.
The document proposes a project to implement embedded systems in a manufacturing process to automate controls and improve quality. It outlines objectives to integrate 10 embedded systems to standardize processes, reduce human errors, and lower costs. A cost-benefit analysis estimates the total costs of hardware, software, assembly, programming and maintenance to be $14,440. The proposal claims embedded systems can increase productivity while maintaining quality standards and that the costs will be offset by improved efficiency over time.
Controlling SOA in Support of Operational Improvement (ISPE PE Vol 31 No 4 - ...David Stokes
The document discusses an approach to leveraging GAMP good practices to facilitate the qualification and validation of IT middleware and Service Oriented Architecture (SOA) in the life sciences industry. It presents SOA as a way to more efficiently integrate systems and automate business processes. However, adoption has been limited due to a lack of guidance on how to ensure middleware and SOA are compliant. The article proposes categorizing SOA components as either utility services, which can be qualified as IT infrastructure, or business services, which usually require validation. It provides a framework to help assess and control SOA in a risk-based manner.
1. The document describes a prototype tool for modeling manufacturing decisions in cell culture production.
2. It uses a hierarchical modeling approach and was implemented using object-oriented programming to model tasks, resources, and process streams with flexibility.
3. A case study demonstrates how the tool can evaluate the effects of manufacturing options on resource demands, costs, and strategic goals to help companies optimize their processes.
Applying Automation to What Ails HealthcareCognizant
Process automation could enable healthcare organizations to deliver streamlined but richer member and patient experiences while reducing costs. Yet our research shows payers may be approaching automation too conservatively and missing opportunities for substantial cost savings and more efficient operations.
DEMATEL (siglas en inglés de Decision Making Trial and Evaluation Laboratory) es una técnica desarrollada en 1972 por Fontela y Gabus en el Centro de Investigación de Ginebra del Battelle Memorial Institute. Se utiliza para analizar la interdependencia (relación o influencia) entre componentes, variables o atributos de un sistema complejo, identificar aquellos que son críticos y estudiar sus relaciones causa-efecto, utilizando un diagrama de relaciones de
DEMATEL (siglas en inglés de Decision Making Trial and Evaluation Laboratory) es una técnica desarrollada en 1972 por Fontela y Gabus en el Centro de Investigación de Ginebra del Battelle Memorial Institute. Se utiliza para analizar la interdependencia (relación o influencia) entre componentes, variables o atributos de un sistema complejo, identificar aquellos que son críticos y estudiar sus relaciones causa-efecto, utilizando un diagrama de relaciones de DEMATEL (siglas en inglés de Decision Making Trial and Evaluation Laboratory) es una técnica desarrollada en 1972 por Fontela y Gabus en el Centro de Investigación de Ginebra del Battelle Memorial Institute. Se utiliza para analizar la interdependencia (relación o influencia) entre componentes, variables o atributos de un sistema complejo, identificar aquellos que son críticos y estudiar sus relaciones causa-efecto, utilizando un diagrama de relaciones de DEMATEL (siglas en inglés de Decision Making Trial and Evaluation Laboratory) es una técnica desarrollada en 1972 por Fontela y Gabus en el Centro de Investigación de Ginebra del Battelle Memorial Institute. Se utiliza para analizar la interdependencia (relación o influencia) entre componentes, variables o atributos de un sistema complejo, identificar aquellos que son críticos y estudiar sus relaciones causa-efecto, utilizando un diagrama de relaciones de
EMATEL (siglas en inglés de Decision Making Trial and Evaluation Laboratory) es una técnica desarrollada en 1972 por Fontela y Gabus en el Centro de Investigación de Ginebra del Battelle Memorial Institute. Se utiliza para analizar la interdependencia (relación o influencia) entre componentes, variables o atributos de un sistema complejo, identificar aquellos que son críticos y estudiar sus relaciones causa-efecto, utilizando un diagrama de relaciones de
DEMATEL (siglas en inglés de Decision Making Trial and Evaluation Laboratory) es una técnica desarrollada en 1972 por Fontela y Gabus en el Centro de Investigación de Ginebra del Battelle Memorial Institute. Se utiliza para analizar la interdependencia (relación o influenci
Project manufacturers face unique challenges in managing complex projects with low production volumes and frequent changes. Using manual systems to manage information leads to inefficiencies and increased costs. Implementing manufacturing execution systems (MES) that integrate with ERP systems allows timely sharing of production information across the organization. This improves visibility, reduces errors, and enables better decision making, leading to increased operational performance through higher efficiency, quality and lower costs. Studies show manufacturers using MES see significant improvements in key financial metrics like return on assets. By facilitating integrated information flow, MES gives project manufacturers the agility needed to thrive in challenging market conditions.
Innovating Quality Control in the Semiconductor Manufacturing Industry.pptxyieldWerx Semiconductor
The semiconductor manufacturing industry, a high-volume manufacturing environment characterized by its intricacy, stands as a testament to precision and performance. To ensure optimal outcomes, it is vital to maintain consistent quality control, with a special emphasis on the rectification of tool deterioration. Implementing innovative strategies related to process control monitoring can mitigate this problem and set a path towards a 'zero equipment failure' environment.
Similar to Has MES Reached Maturity in the Pharmaceutical & Medical Devices Industry...? (20)
SATTA MATKA DPBOSS KALYAN MATKA RESULTS KALYAN CHART KALYAN MATKA MATKA RESULT KALYAN MATKA TIPS SATTA MATKA MATKA COM MATKA PANA JODI TODAY BATTA SATKA MATKA PATTI JODI NUMBER MATKA RESULTS MATKA CHART MATKA JODI SATTA COM INDIA SATTA MATKA MATKA TIPS MATKA WAPKA ALL MATKA RESULT LIVE ONLINE MATKA RESULT KALYAN MATKA RESULT DPBOSS MATKA 143 MAIN MATKA KALYAN MATKA RESULTS KALYAN CHART
63662490260Kalyan chart, satta matta matka 143, satta matka jodi fix , matka boss OTC 420, Indian Satta, India matka, matka ank, spbossmatka, online satta matka game play, live satta matka results, fix fix fix satta namber, free satta matka games, Kalyan matka jodi chart, Kalyan weekly final anl matka 420
𝐔𝐧𝐯𝐞𝐢𝐥 𝐭𝐡𝐞 𝐅𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐄𝐧𝐞𝐫𝐠𝐲 𝐄𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲 𝐰𝐢𝐭𝐡 𝐍𝐄𝐖𝐍𝐓𝐈𝐃𝐄’𝐬 𝐋𝐚𝐭𝐞𝐬𝐭 𝐎𝐟𝐟𝐞𝐫𝐢𝐧𝐠𝐬
Explore the details in our newly released product manual, which showcases NEWNTIDE's advanced heat pump technologies. Delve into our energy-efficient and eco-friendly solutions tailored for diverse global markets.
SATTA MATKA DPBOSS KALYAN MATKA RESULTS KALYAN CHART KALYAN MATKA MATKA RESULT KALYAN MATKA TIPS SATTA MATKA MATKA COM MATKA PANA JODI TODAY BATTA SATKA MATKA PATTI JODI NUMBER MATKA RESULTS MATKA CHART MATKA JODI SATTA COM INDIA SATTA MATKA MATKA TIPS MATKA WAPKA ALL MATKA RESULT LIVE ONLINE MATKA RESULT KALYAN MATKA RESULT DPBOSS MATKA 143 MAIN MATKA KALYAN MATKA RESULTS KALYAN CHART
Satta matka fixx jodi panna all market dpboss matka guessing fixx panna jodi kalyan and all market game liss cover now 420 matka office mumbai maharashtra india fixx jodi panna
Call me 9040963354
WhatsApp 9040963354
SATTA MATKA DPBOSS KALYAN MATKA RESULTS KALYAN CHART KALYAN MATKA MATKA RESULT KALYAN MATKA TIPS SATTA MATKA MATKA COM MATKA PANA JODI TODAY BATTA SATKA MATKA PATTI JODI NUMBER MATKA RESULTS MATKA CHART MATKA JODI SATTA COM INDIA SATTA MATKA MATKA TIPS MATKA WAPKA ALL MATKA RESULT LIVE ONLINE MATKA RESULT KALYAN MATKA RESULT DPBOSS MATKA 143 MAIN MATKA KALYAN MATKA RESULTS KALYAN CHART INDIA MATKA KALYAN SATTA MATKA 420 INDIAN MATKA SATTA KING MATKA FIX JODI FIX FIX FIX SATTA NAMBAR MATKA INDIA SATTA BATTA
SATTA MATKA DPBOSS KALYAN MATKA RESULTS KALYAN CHART KALYAN MATKA MATKA RESULT KALYAN MATKA TIPS SATTA MATKA MATKA COM MATKA PANA JODI TODAY BATTA SATKA MATKA PATTI JODI NUMBER MATKA RESULTS MATKA CHART MATKA JODI SATTA COM INDIA SATTA MATKA MATKA TIPS MATKA WAPKA ALL MATKA RESULT LIVE ONLINE MATKA RESULT KALYAN MATKA RESULT DPBOSS MATKA 143 MAIN MATKA KALYAN MATKA RESULTS KALYAN CHART
Prescriptive analytics BA4206 Anna University PPTFreelance
Business analysis - Prescriptive analytics Introduction to Prescriptive analytics
Prescriptive Modeling
Non Linear Optimization
Demonstrating Business Performance Improvement
Unlocking WhatsApp Marketing with HubSpot: Integrating Messaging into Your Ma...Niswey
50 million companies worldwide leverage WhatsApp as a key marketing channel. You may have considered adding it to your marketing mix, or probably already driving impressive conversions with WhatsApp.
But wait. What happens when you fully integrate your WhatsApp campaigns with HubSpot?
That's exactly what we explored in this session.
We take a look at everything that you need to know in order to deploy effective WhatsApp marketing strategies, and integrate it with your buyer journey in HubSpot. From technical requirements to innovative campaign strategies, to advanced campaign reporting - we discuss all that and more, to leverage WhatsApp for maximum impact. Check out more details about the event here https://events.hubspot.com/events/details/hubspot-new-delhi-presents-unlocking-whatsapp-marketing-with-hubspot-integrating-messaging-into-your-marketing-strategy/
SATTA MATKA DPBOSS KALYAN MATKA RESULTS KALYAN CHART KALYAN MATKA MATKA RESULT KALYAN MATKA TIPS SATTA MATKA MATKA COM MATKA PANA JODI TODAY BATTA SATKA MATKA PATTI JODI NUMBER MATKA RESULTS MATKA CHART MATKA JODI SATTA COM INDIA SATTA MATKA MATKA TIPS MATKA WAPKA ALL MATKA RESULT LIVE ONLINE MATKA RESULT KALYAN MATKA RESULT DPBOSS MATKA 143 MAIN MATKA KALYAN MATKA RESULTS KALYAN CHART
Enhancing Adoption of AI in Agri-food: IntroductionCor Verdouw
Introduction to the Panel on: Pathways and Challenges: AI-Driven Technology in Agri-Food, AI4Food, University of Guelph
“Enhancing Adoption of AI in Agri-food: a Path Forward”, 18 June 2024
Enhancing Adoption of AI in Agri-food: Introduction
Has MES Reached Maturity in the Pharmaceutical & Medical Devices Industry...?
1. Has MES Reached Maturity in the Pharmaceutical & Medical Devices Industry...?
(Topic on: MESA - Manufacturing Execution System, Manufacturing Operations Management, MOM, MES)
Compliance, process optimization, increasing profit, improving the supply chain and aligning to corporate standards are driving
investment of Information Technology (IT) in the pharmaceutical industry.
According to a report in October 2010 by Gartner Group, there is a need for integrated IT manufacturing technologies, reflected in
the fact that corporate IT budgets have increased for manufacturing operations from 3% in 2001 to 19% in 2007 (1). The
pharmaceutical industry has adopted this strategic initiative of integrating manufacturing IT and is benefiting through improved
quality and production efficiencies.
Trends of IT in Manufacturing: IT can play a role at all levels of manufacturing operations however it is becoming especially evident
within Manufacturing Operations Management (MOM) level. Advancements in technology such as Service Oriented Architecture
(SOA) frameworks has enabled IT in manufacturing to shift from being data centric to process centric; therefore, IT is becoming
seamless within manufacturing operations. By not restricting technology at the MOM level, activities such as Electronic Batch
Records (EBR), real-time reporting, Enterprise Resource Planning (ERP) and equipment integration all have allowed pharmaceutical
companies to maximize return on IT investment, improve quality, provide a platform for continuous improvement and ultimately
increase profits.
MES in the Pharmaceuticals Industry: Manufacturing Execution Systems (MES) aggregates a number of the technologies deployed
at the MOM level. MES as a technology has been successfully deployed within the pharmaceutical industry since the Food and Drug
Administration (FDA) decreed the final 21 Part 11 regulations on 21 March 1997. These provided criteria for acceptance by the FDA,
under certain circumstances, of electronic records, electronic signatures and handwritten signatures executed to electronic records
as equivalent to paper records and handwritten signatures executed on paper. Over 16 years on and the technology associated with
MES has matured positively and is fast becoming a recognized best practice across all life science regulated industries. This is borne
out by the fact that green-field manufacturing sites are starting with an MES in place, that is, paperless manufacturing from day
one.
The amount of IT applied to an MES project is dependent on the customer’s business needs. At a minimum, an MES should strive to
replace paper batch records with an EBR. Other functionality that can be applied include automated material weigh & dispense and
integration to ERP systems; therefore, helping the optimization of inventory levels and production planning. MES can also be
integrated at the factory level, potentially giving complete control over the entire enterprise. This level of control helps ensure ‘right-
first-time’ manufacturing and total enterprise visibility. The MES acts as a central system with effective interoperations with other
manufacturing systems and departments such as operations, quality, maintenance and inventory control. The key to a successful
MES implementation is applying the right level of IT to maximize Return on Investment (ROI).
Shown in the figure 1.0 is a representation of MES within a typical pharmaceutical manufacturing operation:
2. Figure 1.0: MES in Accordance with the ISA95 Model
This diagram is a representation of where MES would reside in a typical pharmaceutical facility in accordance with the ISA S95
standard (2). The ISA S95 standard defines a model for manufacturing operations, including the reporting and analysis functions
that are critical to effective manufacturing. The business planning and logistics (Level 4) functions are supported by ERP, Product
Lifecycle Management (PLM) or Supply Chain Management (SMC) applications. The plant floor systems (Levels 2 and 3) are made up
of Laboratory Information Management Systems (LIMS), OPC data integration tools, data historians, Statistical Process Control (SPC),
MES, control systems and database tools.
Has the Pharmaceutical Industry Adopted MES…?
In preparation for this article, a survey was carried out by the author to establish the level of electronic MES deployment within the
pharmaceutical industry. The survey was conducted between January and February 2013. Over 400 senior managers and system
analysts from across the globe working in pharmaceutical companies were contacted. In total, 84 responses were documented, of
which 47% of respondents stated that electronic MES has already been deployed in specific manufacturing facilities. A further
analysis was conducted of those facilities that had deployed MES in relation to stored batch records. Only 31% of companies had
deployed full paperless solutions with the majority deploying a combination of paper and electronic batch records.
3. Figure 2.0: Batch Record Method with MES in the Pharmaceutical Industry
So what do the regulatory agencies think of MES? As far back as 2004, reports were published highlighting the compliance benefits
of MES in the life science industry. In an article titled ‘MES Reduces FDA Compliance Costs’ (3), Quality Magazine discusses:
‘The underlying premise of today's interpretation of the regulations is to ensure quality or risk management and risk mitigation by
defining a management methodology for designing quality into the manufacturing process instead of attempting to build quality into
products through inspection. The goal of manufacturers and the FDA is to provide and deliver safe and effective products.
However, FDA compliance historically has been an expensive, albeit necessary, proposition. As the life science industry becomes
more competitive, reducing the cost of compliance is as important to success as controlling costs, quality and time-to-market.
A Manufacturing Execution System (MES) helps bridge the gap between regulatory control, operational control and case
management.’
Since 2004, the FDA have audited pharmaceutical facilities with MES in place. It has been the experience of the author that these
systems are welcomed by the FDA and there have been no citations against compliant MES implementations.
4. Examining the Principle Drivers for Adopting MES in the Pharmaceutical Industry: MES states that the benefits for recipe-
driven operations such as pharmaceutical production processes include:
improved scheduling and resource utilization
improved manufacturing flexibility and process changeover
reduced Work in Progress (WIP) and improved material tracking
shorter production cycles
enforced sequence of operations
reduced production record errors, electronic or hybrid
improved visibility, accuracy and consistency of manufacturing data, enhancing decision support, Process Analytical
Technology (PAT), and investigations capabilities
minimized product recalls
increased plant reliability
realize paperless manufacturing
automated Key Performance Indicator (KPI) generation and reporting, such as an Overall Equipment Efficiency (OEE)
calculation
support knowledge management and PAT
reduce Quality Unit resources required for day to day operations by providing functionality, such as Electronic Production
Records (EPR) and Review by Exception (RBE)’
As part of the survey conducted in preparation for this article, the respondents who had MES installed were asked to choose the
primary and secondary drivers for implementing electronic MES solutions from the following five categories:
1. Quality
2. Production
3. Inventory
4. Financial
5. Corporate
5. The results of the survey can be seen here:
Figure 3.0: Primary and Secondary Drivers for MES in the Pharmaceutical Industry
From studying these results, it is evident that improving quality and production are the primary drivers for implementing electronic
MES as they account for almost 80% of the combined drivers.
The benefits to MES can be quantitative and qualitative. Quantitative benefits can be measured for financial outcomes such as
calculating an ROI, whereas qualitative benefits are more subjective, but no less important. When selling an MES internally, the
importance of qualitative benefits should not be ignored, as inevitably measuring MES on quantitative benefits alone is a very hard
sell.
Quantitative Benefits/Tangible Cost Saving to MES:
Reduced Cost of Quality: The number of deviations associated with paper batch records is an example of the cost of quality. It is the
direct experience of the author that with the implementation of MES, recorded deviations can be reduced by over 50%. With paper
based systems, companies can maintain high levels of quality; however, there is a high cost associated with ensuring this quality
level. An MES reduces the cost of quality but also ensures there is no drop in quality level.
Cost of Storing Batch Records (Quality): Companies have on-going costs associated with the storing and retrieval of paper batch
records. With the introduction of an MES, major cost reductions can be achieved. (However, existing records still need to be held in
accordance with regulations applied by the relevant agency.)
Improved Batch Release Time (Production): Review by exception can be achieved with a mature MES. EBRs typically require
review and release by the operations and quality departments; however, this is significantly less than a paper review process. In some
cases, pharmaceutical manufacturers have implemented Review-by-Exception with MES.
6. Production Capacity Increase: With an MES in place, companies can expect to improve the capacity of their manufacturing plant
by maximizing MES lean initiatives. This enables companies to take up any future or short-term demand without hiring extra
resources or overtime.
Better Financial Costing: MES can help enable companies implement multi-level Bill of Materials (BOMs) with increased visibility
on the manufacturing. Also, MES will lead to improved routing of material and better analysis of variance. It will enable the setting
up new cost centers and provide all-in-all improved standard costing through the manufacturing process.
Inventory Reductions: Companies with little visibility into the manufacturing floor maintain a high level of inventory. MES solutions
create near real-time reports using quality-approved data therefore allowing companies significant scope to reduce inventory levels.
Inventory Management: An MES improves warehouse efficiencies through stock movements and transactions being real time,
paperless cycle counting and benefits associated with a paperless warehouse. This means there is a reduction in warehouse activities
and a reduced effort for the quality department of incoming inspection labelling.
Qualitative Benefits/Intangible Cost Savings to MES:
Enforced Compliance (Quality): MES provides enforced compliance in many aspects of manufacturing including enforced sequence
of activities, equipment usability verification prior to use, material status checking prior to use, user group membership prior to
performing system functions and many more.
Cost of Audit Preparation (Quality): MES helps close open deviations by putting in place rigid corrective actions such as enforced
in-process inspections. This compares to a paper system that will rely on procedural updates and training, which are not as effective
as an enforced quality check. During audits, MES is more efficient at retrieving information, which means shorter and better audits.
Electronic Equipment Management (Production): MES enables the efficient creation and automatic maintenance of electronic
logbooks. Comprehensive status monitoring effectively prevents the use of wrong equipment. These equipment states might include
planned or unplanned maintenance, cleaning and calibration. Business rules can be applied to manage the status of the equipment.
MES can ensure that work in progress is not processed through a particular machine when flagged for being out of compliance.
Multiple Batch/Shift Production: One of the biggest benefits from MES is product changeover and new product Master Batch
Record (MBR) creation or updates. The more products handled in production or packaging, the less effective paper-based systems
become.
Transparent Process Data Evaluation (Corporate): MES stores data in a relational format that is available for integration and
analysis with other manufacturing intelligence information.
Business Process Standardization (Corporate): An MES program can be used as a mechanism to define and implement common
business processes as well as lean manufacturing processes.
7. Untapped Capital (Financial): MES accelerates the manufacturing learning curve across all facets of the organization because an
MES implementation requires complete involvement and transparency of roles between different departments. This interaction
between departments will unleash actionable intelligence, that is, employees adding valuable input into other functional areas.
Employees can be empowered with new more value-added roles now that the control of the manufacturing process is automated.
Support the Extended Supply Chain Strategy (Inventory): MES solutions typically integrate with ERP systems. MES helps refine
ERP scheduling functions to the day or even hour, whereas the ERP focuses on months or weeks. This extra level of planning helps
ensure that order times are minimized and there is increased visibility into the manufacturing floor.
Corporate Business Process Management (BPM): BPM is the activity of managing your whole process, from dock to stock as well as
supporting functions. As part of a demand-driven manufacturing process, increasing efficiency is critical. Real-time information from
the manufacturing process is needed to prevent problems, drive quality, and enable the flexibility your customers require. MES
enables this reach into the manufacturing process and is seen as a key requirement for successful BPM.
Challenges Associated with an MES Implementation:
An MES project within the pharmaceutical industry is treated as an enterprise software solution, similar to ERP projects. However,
the major difference between MES and ERP projects is that MES should be led by operations whereas ERP projects are typically IT
led. MES touches every aspect of the manufacturing floor and can become very complex. For this reason, companies have
concentrated on ERP and automation projects as they do not have as many dependencies. MES is often the final hurdle to complete
data integration across the ISA S95 model.
Implementing a complete MES solution into an existing pharmaceutical manufacturing facility could take in excess of four years. In
year one, the strategy applied could be to expand the functionality of the ERP layer with improved material tracking on the
production floor and warehouse. Lean initiatives can be implemented to ensure that the manufacturing and business processes are
‘MES ready’.
Into year two, focus might shift to investing into the visualization layer of automation, such as investments into Distributed Control
Systems (DCS) and Data Historian technologies. The strategy might also involve investing into an automatic weight & dispense
solution, either provided by an ERP or MES vendor; therefore, improving the control of raw materials on the production floor. On to
year three and the company is now ‘MES ready’. An MES solution can be deployed with the purpose of replacing a paper batch record
with an EBR. Finally, in year four, the focus will shift to fully integrating the MES solution into the automation and ERP layers.
MES teams typically consist of a steering committee or group with sub-groups concentrating on production, quality, validation, IT,
change management, inventory, training and maintenance requirements. Group sizes can be from 6 to over 20 directly involved in
the MES project. Factoring in the human resources required, time scale, software licenses, hardware costs, initial negative impact of
change on production, a budget of 3-5 million euros is not unusual for an MES project deployed in a small to medium sized
pharmaceutical operation, that is 200-500 employees.
8. MES solutions are being successfully deployed in the pharmaceutical industry; however, deciding to implement an MES solution is
not a decision to be taken lightly. Careful planning and education into what MES is, is key. Organizations such as the Manufacturing
Enterprise Solutions Association (MESA) (6) have been established to promote best practices and education in MES. With proper
planning and education, a business case for an MES solution can be established.
The Technology Adoption Cycle and MES in the Pharmaceutical Industry:
Geoffrey A. Moore in this book ‘Crossing the Chasm’ (5) discusses a concept of technology adoption. Moore breaks technology
adoption into five phases. Cracks exist between the phases and some technologies that fail to clear these cracks fade away. Examples
of such technologies that were not fully adopted or did not reach maturity include Windows ME, the Palm Pilot and social networking
site Bebo. Moore (5) goes onto discuss ‘the notion that part of what defines a high-tech market is the tendency of its members to
reference each other when making buying decisions is absolutely key to successful high-tech marketing.’ The critical point identified
by Moore where technologies either get adopted or fail is the chasm, the crack that exists between the ‘Early Adopters’ and ‘Early
Majority’ phases.
So has MES in the pharmaceutical industry crossed the chasm? Based on the research conducted in conjunction with this article,
yes it has. It is firmly placed in the ‘Early Majority’ phase as demonstrated in the following diagram.
Figure 4.0: Crossing the Chasm of MES in the Pharmaceutical Industry
9. People who are deemed to be in the ‘Early Majority’ phase are pragmatists. Moore (5) says about the Early Majority that ‘they care
about the company they are buying from, the quality of the product they are buying, the infrastructure of supporting products and
system interfaces, and the reliability of the service they are going to get…’ All these factors are very important considerations when
selecting a technology in the pharmaceutical industry. There are thousands of MES products available. MES is being deployed in the
pharmaceutical industry and there is an array of proven solutions available.
The S-Curve and ERP in the Pharmaceutical Industry:
Another methodology used to describe technology adoption is the S-Curve. The S-Curve describes technological evolution and
suggests that technologies evolve through an initial period of slow growth, followed by one of fast growth culminating in a plateau. It
also breaks the take up of technologies into different phases; however, it differs from Moore’s (5) model in that it accounts for shifts in
technology during the adoption cycle. Traditionally, MES has been a site-specific initiative but with increasing globalization,
companies are now aligning not just their enterprise systems such as ERP but are focusing on manufacturing systems such as MES.
Software as a Service (SaaS) and cloud computing is arguably causing a shift in the technology adoption cycle in both MES and ERP.
Cloud computing is a model whereby the computer hardware and software services are typically (but not always) offered as a service
in a remote data center. This compares to deploying hardware and software on local sites.
Figure 5.0: S-Curve Technology Adoption
10. Manufacturing: With emerging technologies such as cloud computing and increasing globalization, the dynamics of manufacturing
are changing. Manufacturing plants are integral parts of the overall supply chain and need to provide real-time data. This increases
the focus on reporting from manufacturing and MES plays a crucial role in insuring the accuracy and availability of data. ERP
systems handle weekly or perhaps in some cases daily information. The supply chain is demanding more refined data. MES solutions
typically are designed to report at an hourly rate or with less frequency, therefore meeting the requirement of the overarching supply
chain.
MESA, in a recent white paper, introduces the concept of Manufacturing. As discussed earlier, companies are shifting manufacturing
focus from data centric to process centric, and advances in the design of large software applications, through the use of frameworks
such as Service Oriented Architecture (SOA) are enabling this shift. MESA discuss (7):
‘The manufacturing operations‐specific requirements for SOA are called Manufacturing. technologies are differentiated from the so‐
called Manufacturing architectures based on stand‐alone client/server data base applications that attempted to represent business
process modelling through point‐to point interfaces and custom data transformation between applications.’
By deploying technologies, companies can meet the demands driven by the overall supply chain. Without an MES, this cannot be
achieved efficiently. Companies will have to decide whether technologies are feasible for the deployment of MES. The technology is
not as mature as client/server based solutions; concerns exist in relation to data security and a total reliance of IT networks.
Individual companies should weigh up benefits of these new technologies, such as economies of scale, shared services and aligning to
enterprise strategies, before deciding on a deployment approach of a technology set.
11. Figure 6.0: Manufacturing and MES
Pharmaceutical Manufacturing Without an Electronic MES: Due to the complexities at the MOM level, financial constraints and
availability of key personnel investments in solutions such as MES are deferred. This is very understandable as manufacturing
organizations need to be ready and able to clearly define their requirements for a potential solution. The downside to this strategy is a
break in data flow, that is, inventory information available on the ERP system and process information available from equipment
sets, but no one system aggregating the data together. This impacts on the availability and quality of data, therefore negatively
impacting on traceability. It is also a requirement within FDA-regulated industry to retain MOM data associated with products and
processes that directly impact on the production of finished goods. With e-pedigree and serialization pending, this break in data flow
requires companies to invest a lot of time in managing the data on paper.
This data is critical in the pharmaceutical industry. It is a rich, real-time and most importantly a quality approved (that is, collected,
stored and maintained in accordance to regulatory requirements) source of data on which any decisions pertaining to manufacturing
can confidently be made. The data will also help resolve traceability issues arising at the MOM level, as it plugs the gap between
enterprise and manufacturing operations management.
In Conclusion: Pharmaceutical companies that have adopted MES are gaining a competitive advantage with improved quality, better
traceability, maximized lean initiatives, flexible manufacturing processes, improved compliance, complete business process
management and accurate, real-time reporting. Companies that do not adopt this technology risk losing a share of existing and new
market opportunities. This is borne out by the fact that new pharmaceutical facilities are starting with an MES in place, that is,
paperless manufacturing from day one.
12. Of those companies surveyed in conjunction with the article, over 80% have an ERP system in place. MES adoption is lagging behind
ERP, but technologies become more prevalent, MES will become an integral part and critical component of the overall supply chain.
MES will continue to be adopted and eventually align with ERP.
Figure 7.0: MES and ERP Adoption in the Pharmaceutical Industry
Implementing MES is not a decision that can be taken lightly. Every aspect of the manufacturing process will be impacted by an MES
implementation; however, companies are successfully deploying MES and reaping the reward. MES has crossed the technology
chasm and is reaching maturity in the pharmaceutical industry. Don’t get left behind.